Prometheus Laboratories Inc.
Overview
Prometheus Laboratories Inc. is a specialty pharmaceutical and diagnostics company committed to the intersection of inflammation and immunology diagnostics and treatment. As a subsidiary of Nestlé Health Science, Prometheus strives to bring innovative solutions to meet the unmet needs of patients.
Therapeutic areas
API / Drug Master Files
Prometheus Laboratories Inc. holds 0 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- AZATHIOPRINE 50 MG TABLETS AND PLACEBO TABLETSInactive2005-09-09
FDA compliance signals
3 FDA enforcement records linked to this company.
- 4832016-03-25
Failure to develop written procedures
- recall — Class II2014-11-26
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
- recall — Class II2012-08-29
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
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